NCB PLATING SYSTEM
FDA 510(k) clearance K042695 · decided 2004-10-29
Clearance details
- K-number
- K042695
- Device name
- NCB PLATING SYSTEM
- Applicant
- Zimmer GmbH
- Decision
- Substantially Equivalent
- Date received
- 2004-09-30
- Decision date
- 2004-10-29
- Days to decision
- 29 days
- Clearance type
- Traditional
- Product code
- HRS
- Device class
- 2
- Regulation number
- 888.3030
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Warsaw, IN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| The NCB Polyaxial Locking Plate System NCB screws 26mm: 02.03155.026, non-sterile Product recall (Z-2187-2012) | Zimmer, Inc. | 2012-08-10 |